Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Other: breast imaging study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00627614

P30CA015083 (U.S. NIH Grant/Contract)

284-06

CDR0000583016 (Other Identifier)

Details and patient eligibility

About

RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer.

PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.

Full description

OBJECTIVES:

• To study in vivo detection of breast masses by vibro-acoustography (VA) imaging.
• To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.

OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.

Enrollment: 147 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Suspiciuos breast lesions identified as BI-RADS 4 or 5 and 3
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• Not pregnant
• No condition that does not allow proper use of study imaging devices

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

breast imaging study

Experimental group

Treatment:

Other: breast imaging study